BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS ANGIOGRAPHIC CATHETER

    MDR report key: 7909605 · Received September 26, 2018

    Report

    Report Number
    9681834-2018-00167
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 26, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K090040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K915414 H6 - RESULTS - 3252 IS BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 213 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. H6 - CONCLUSION - 4310 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 67 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE SHAFT HAD BEEN FRACTURED AT APPROXIMATELY 150MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION OF THE FRACTURES FROM THE LATERAL SIDES REVEALED THAT THE SEGMENT ADJACENT TO THE FRACTURE ENDS HAD BEEN STRETCHED. THERE WAS NO TRACE OF SCRATCHES AROUND THE FRACTURE ENDS. MAGNIFYING INSPECTION OF THE FRACTURE CROSS-SECTIONS REVEALED THAT THE EDGES OF THE FRACTURED SHAFT HAD BEEN FLARED OUTWARD. FURTHER MAGNIFYING INSPECTION OF THE REMAINDERS OF THE DEVICE DID NOT FIND ANY OTHER ANOMALY. THE OUTSIDE AND INSIDE DIAMETERS WERE DETERMINED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET THE SPECIFICATIONS. THE BENDING STRENGTH WAS DETERMINED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO BE NORMAL WITH NO GENERATION OF A CRACK. REPRODUCTIVE TESTING WAS PERFORMED; A CATHETER TEST SAMPLE WAS EXPOSED TO BENDING FORCE ON THE NON-BRAIDED SEGMENT, WHERE THE SHAFT WAS FLATTENED AND THE LUMEN WAS CLOSED. IN THIS STATE, THE TEST SAMPLE WAS PRESSURIZED. THE TEST SAMPLE GOT RUPTURED AT THE BENT PORTION. SUBSEQUENTLY, WHEN PULLING FORCE WAS APPLIED TO THE RUPTURED SEGMENT, THE SHAFT GOT FRACTURED INTO TWO PIECES AT THE RUPTURE. MAGNIFYING INSPECTION OF THE FRACTURE CROSS-SECTIONS REVEALED THAT THE SHAFT HAD BEEN STRETCHED ON THE SEGMENT ADJACENT TO THE FRACTURE ENDS, WITH THE EDGES OF THE FRACTURED SHAFT HAVING BEEN FLARED OUTWARD. THE DAMAGE SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO A BENDING FORCE DUE TO SOME FACTOR(S) AND THE SHAFT GOT KINKED. IN THIS STATE, WHEN CONTRAST MEDIA WAS INJECTED INTO THE ACTUAL SAMPLE, THE PRESSURE WHICH EXCEEDED THE STRENGTH LIMIT OF THIS PRODUCT WAS GENERATED IN THE LUMEN DUE TO THE KINK AND THE SHAFT GOT RUPTURED. DURING SUBSEQUENT MANIPULATIONS, THE ACTUAL SAMPLE WAS SUBJECTED TO PULLING FORCE AND GOT FRACTURED AT THE RUPTURE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THE IFU STATES: " BEFORE STARTING INFUSION, VERIFY THAT THE CATHETER HAS NOT BEEN KINKED OR BLOCKED. FAILURE TO ABIDE BY THIS WARNING MAY CAUSE THE CATHETER TO BREAK/RUPTURE/SEPARATE, RESULTING IN DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING AN EMBOLIZATION, THE COBRA 2 GLIDECATH RUPTURED/TRANSECTED SPONTANEOUSLY, LEAVING HALF THE CATHETER IN THE PATIENT. THE REMAINING HALF OF THE C2 CATHETER WAS RETRIEVED WITH A SNARE. THE PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751185 RADIFOCUS ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA NA 180302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention